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Fennec Pharmaceuticals
Reports First Quarter 2024 Financial Results and Provides Business Update
2024-05-14
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Achieved First Quarter 2024 Total Net Revenues of $25.4 Million, Including $18.0 Million in Licensing Revenue from Recently Announced
Norgine
Transaction Executed Exclusive Licensing Agreement with
Norgine
to Commercialize
PEDMARQSI
™ in Europe, Australia, and New Zealand Amended PEDMARK Permanent J-code 07901 Became Effective April 1, 2024 Company Has Approximately $51 Million in Cash, Cash Equivalents, and Investment Securities Management to Host Conference Call Today at 8:30 a.m. ET RESEARCH TRIANGLE PARK, N.C., May 14, 2024 (GLOBE NEWSWIRE) --
Fennec Pharmaceuticals Inc.
(NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company, today reported its financial results for the first quarter ended March 31, 2024, and provided a business update. “We made significant progress with our strategic plans to refocus our organizational efforts in the outpatient oncology community where
PEDMARK
use has been endorsed by the NCCN in the adolescent and young adult (AYA) population. Effective April 1, CMS has amended our permanent J-code to specify the non-interchangeability of PEDMARK with other formulations of
sodium thiosulfate (STS)
. With the successful execution of the
Norgine
Norgine
EU licensing agreement, we are well funded and confident in the significant market opportunity in front of us,” said Rosty Raykov, chief executive officer of
Fennec Pharmaceuticals
. Recent Developments and Highlights: Achieved PEDMARK net product revenue of approximately $7.4 million in the first quarter of 2024 and total net revenues of $25.4 million, which is inclusive of $18.0 million in revenue from the
Norgine
transaction. Amended permanent J-Code, which became effective on April 1, 2024, now clearly specifies
PEDMARK
® from other formulations of
sodium thiosulfate (STS)
. Announced execution of exclusive licensing agreement with
Norgine
to commercialize
PEDMARQSI
in Europe, Australia, and New Zealand.
Fennec
received approximately $43.2 million upfront and has the potential to receive up to approximately $230 million in additional commercial and regulatory milestones, and double-digit tiered royalties. Within the first quarter,
Fennec
participated in eleven regional oncology conferences, as well as seven key scientific meetings, including the American Society of Pediatric Hematology/Oncology, the Community Oncology Alliance, the National Comprehensive
Cancer
Network, and the American Academy of Audiology annual conferences. Financial Results for the First Quarter 2024 Net Sales – The company recorded net product sales of $7.4 million and $18.0 million in licensing revenue for total net sales of $25.4 million for the three-month period ended March 31, 2024, compared to $1.7 million in product sales and no licensing revenue for the same period in 2023. The Company recorded discounts and allowances against sales in the amount of $2.1 million and cost of products sold of $0.6 million for the three-month period ended March 31, 2024. For the same period in 2023, the Company recorded $0.2 million in discounts and allowances and $0.1 million in cost of goods sold. Cash Position – Cash and cash equivalents were $51.2 million at March 31, 2024 and $13.3 million at December 31, 2023. The increase in cash and cash equivalents between March 31, 2024, and December 31, 2023, is the result of cash outlays for operating expenses related to the promotion of our product, selling and marketing expenses and general and administrative expenses, which were offset by cash inflows of approximately $43.2 million from the
Norgine
deal. We anticipate that our cash, cash equivalents and investment securities as of March 31, 2024 will be sufficient to fund our planned operations for at least the next twelve months. Selling and Marketing Expenses –The Company recorded $5.2 million in selling and marketing expenses for the period ended March 31, 2024, compared to $2.5 million for the same period in 2023. The increase is largely related to increased headcount and additional marketing expenses in the comparable period. General and Administrative (G&A) Expenses – G&A expenses increased by approximately $1.6 million over the same period in 2023 to $5.8 million. There was a significant increase in consulting, and professional costs related to European pre-commercialization related expenses in the 2024 period over the comparable period. Net Earnings – Net income for the quarter ended March 31, 2024 was $12.8 million (basic EPS $0.47 per share, diluted EPS $0.41), compared to a net loss of $6.1 million (basic and diluted loss of $0.23 per share) for the same period in 2023. Q1 2024 Conference Call Information Date: Tuesday, May 14, 2024 Time: 8:30 a.m. ET Link: To access the conference call, please register using . Upon registration, a dial-in number and unique PIN will be provided to join the call. To access the live webcast link, log onto and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to listen to the webcast. A webcast replay of the conference call will also be archived on for thirty days. Financial Update The selected financial data presented below is derived from our unaudited condensed consolidated financial statements, which were prepared in accordance with U.S. generally accepted accounting principles. The complete unaudited condensed consolidated financial statements for the period ended March 31, 2024 and management's discussion and analysis of financial condition and results of operations will be available via and All values are presented in thousands unless otherwise noted. Unaudited Condensed Consolidated Statements of Operations (U.S. Dollars in thousands except per share amounts) Three Months Ended March 31, March 31, 2024 2023 Revenue PEDMARK product sales, net $ 7,419 $ 1,677 Licensing revenue 17,958 — Total revenue 25,377 1,677 Operating expenses: Cost of products sold 550 95 Research and development 3 4 Selling and marketing 5,209 2,531 General and administrative 5,872 4,317 Total operating expenses 11,634 6,947 Income/(loss) from operations 13,743 (5,270 ) Other (expense)/income Unrealized foreign exchange loss (38 ) 9 Amortization expense (20 ) (72 ) Unrealized loss on securities (11 ) (30 ) Interest income 197 109 Interest expense (1,034 ) (798 ) Total other expense (906 ) (782 ) Net income/(loss) $ 12,837 $ (6,052 ) Basic net income/(loss) per common share $ 0.47 $ (0.23 ) Diluted net income/(loss) per common share $ 0.41 $ (0.23 ) Weighted-average number of common shares outstanding basic 27,090 26,559 Weighted-average number of common shares outstanding diluted 31,136 26,559
Fennec Pharmaceuticals Inc.
Balance Sheets (U.S. Dollars in thousands) Unaudited Audited March 31, December 31, 2024 2023 Assets Current assets Cash and cash equivalents $ 51,184 $ 13,269 Accounts receivable, net 10,274 8,814 Prepaid expenses 4,488 2,575 Inventory 2,064 2,156 Other current assets 161 44 Total current assets 68,171 26,858 Non-current assets Other non-current assets, net amortization 1,022 6 Total non-current assets 1,022 6 Total assets $ 69,193 $ 26,864 Liabilities and stockholders’ deficit Current liabilities: Accounts payable $ 5,204 $ 3,778 Accrued liabilities 4,363 3,754 Operating lease liability - current 17 21 Contract liability -
Norgine
252 — Total current liabilities 9,836 7,553 Long term liabilities Term loan 30,000 30,000 PIK interest 1,617 1,219 Debt discount (268 ) (288 ) Contract liability -
Norgine
24,994 2 Total long term liabilities 56,343 30,933 Total liabilities 66,179 38,486 Stockholders’ deficit: Common stock, no par value; unlimited shares authorized; 27,105 shares issued and outstanding (2023 ‑27,027) 144,934 144,307 Additional paid-in capital 63,245 62,073 Accumulated deficit (206,408 ) (219,245 ) Accumulated other comprehensive income 1,243 1,243 Total stockholders’ equity/(deficit) 3,014 (11,622 ) Total liabilities and stockholders’ deficit $ 69,193 $ 26,864 Working Capital Working capital Fiscal Period Ended Selected Asset and Liability Data: March 31, 2024 December 31, 2023 (U.S. Dollars in thousands) Cash and equivalents $ 51,184 $ 13,269 Other current assets 16,987 13,589 Current liabilities 9,836 7,553 Working capital $ 58,335 $ 19,305 Selected Equity: Common stock and additional paid in capital 208,179 206,380 Accumulated deficit (206,408 ) (219,245 ) Stockholders’ equity / (deficit) 3,014 (11,622 ) About
Cisplatin-Induced Ototoxicity
Cisplatin
and other platinum compounds are essential chemotherapeutic agents for the treatment of many
pediatric malignancies
. Unfortunately, platinum-based therapies can cause
ototoxicity
, or
hearing loss
, which is permanent, irreversible, and particularly harmful to the survivors of pediatric cancer.i The incidence of
ototoxicity
depends upon the dose and duration of chemotherapy, and many of these children require lifelong hearing aids or cochlear implants, which can be helpful for some, but do not reverse the
hearing loss
and can be costly over time.ii Infants and young children that are affected by
ototoxicity
at critical stages of development lack speech and language development and literacy, and older children and adolescents often lack social-emotional development and educational achievement.iii
PEDMARK
® (
sodium thiosulfate
injection)
PEDMARK
® is the first and only
U.S. Food and Drug Administration (FDA)
approved therapy indicated to reduce the risk of ototoxicity associated with cisplatin treatment in pediatric patients with localized, non-metastatic, solid tumors. It is a unique formulation of
sodium thiosulfate
in single-dose, ready-to-use vials for intravenous use in pediatric patients.7 PEDMARK is also the only therapeutic agent with proven efficacy and safety data with an established dosing paradigm, across two open-label, randomized Phase 3 clinical studies, the Clinical Oncology Group (COG) Protocol ACCL0431 and SIOPEL 6. In the U.S. and Europe, it is estimated that, annually, more than 10,000 children may receive platinum-based chemotherapy. The incidence of
ototoxicity
depends upon the dose and duration of chemotherapy, and many of these children require lifelong hearing aids. There is currently no established preventive agent for this
hearing loss
and only expensive, technically difficult, and sub-optimal cochlear (inner ear) implants have been shown to provide some benefit. Infants and young children that suffer ototoxicity at critical stages of development lack speech language development and literacy, and older children and adolescents lack social-emotional development and educational achievement. PEDMARK has been studied by co-operative groups in two Phase 3 clinical studies of survival and reduction of
ototoxicity
, COG ACCL0431 and SIOPEL 6. Both studies have been completed. The COG ACCL0431 protocol enrolled
childhood cancers
typically treated with intensive
cisplatin
therapy for localized and disseminated disease, including newly diagnosed
hepatoblastoma
,
germ cell tumor
,
osteosarcoma
,
neuroblastoma
,
medulloblastoma
, and other
solid tumors
. SIOPEL 6 enrolled only
hepatoblastoma
patients with localized tumors. Indications and Usage
PEDMARK
® (
sodium thiosulfate
injection) is indicated to reduce the risk of
ototoxicity
associated with
cisplatin
in pediatric patients 1 month of age and older with
localized, non-metastatic solid tumors
. Limitations of Use The safety and efficacy of
PEDMARK
have not been established when administered following
cisplatin
infusions longer than 6 hours.
PEDMARK
may not reduce the risk of
ototoxicity
when administered following longer
cisplatin
infusions, because irreversible ototoxicity may have already occurred. Important Safety Information PEDMARK is contraindicated in patients with history of a severe
hypersensitivity
to
sodium thiosulfate
or any of its components.
Hypersensitivity reactions
occurred in 8% to 13% of patients in clinical trials. Monitor patients for hypersensitivity reactions. Immediately discontinue PEDMARK and institute appropriate care if a
hypersensitivity reaction
occurs. Administer antihistamines or glucocorticoids (if appropriate) before each subsequent administration of
PEDMARK
. PEDMARK may contain
sodium sulfite
; patients with
sulfite
sensitivity may have
hypersensitivity reactions
, including
anaphylactic symptoms
and life-threatening or severe
asthma
episodes.
Sulfite
sensitivity is seen more frequently in people with
asthma
.
PEDMARK
is not indicated for use in pediatric patients less than 1 month of age due to the increased risk of
hypernatremia
or in pediatric patients with
metastatic cancers
.
Hypernatremia
occurred in 12% to 26% of patients in clinical trials, including a single Grade 3 case.
Hypokalemia
occurred in 15% to 27% of patients in clinical trials, with Grade 3 or 4 occurring in 9% to 27% of patients. Monitor serum sodium and potassium levels at baseline and as clinically indicated. Withhold PEDMARK in patients with baseline serum sodium greater than 145 mmol/L. Monitor for signs and symptoms of
hypernatremia
and
hypokalemia
more closely if the glomerular filtration rate (GFR) falls below 60 mL/min/1.73m2. Administer antiemetics prior to each PEDMARK administration. Provide additional antiemetics and supportive care as appropriate. The most common adverse reactions (≥25% with difference between arms of >5% compared to
cisplatin
alone) in SIOPEL 6 were
vomiting
,
nausea
, decreased hemoglobin, and
hypernatremia
. The most common adverse reaction (≥25% with difference between arms of >5% compared to
cisplatin
alone) in COG ACCL0431 was
hypokalemia
. Please see full Prescribing Information for PEDMARK® at: . About
Fennec Pharmaceuticals
Fennec Pharmaceuticals Inc.
is a specialty pharmaceutical company focused on the development and commercialization of
PEDMARK
® to reduce the risk of
platinum-induced ototoxicity
in pediatric patients. Further, PEDMARK received
FDA
approval in September 2022 and
European Commission
approval in June 2023 and U.K. approval in October 2023. PEDMARK has received Orphan Drug Exclusivity in the U.S. For more information, please visit . Forward Looking Statements Except for historical information described in this press release, all other statements are forward-looking. Words such as “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “may,” “will,” or the negative of those terms, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include statements about our business strategy, timeline and other goals, plans and prospects, including our commercialization plans respecting PEDMARK®, the market opportunity for and market impact of
PEDMARK
®, its potential impact on patients and anticipated benefits associated with its use, and potential access to further funding after the date of this release. Forward-looking statements are subject to certain risks and uncertainties inherent in the Company’s business that could cause actual results to vary, including the risks and uncertainties that regulatory and guideline developments may change, scientific data and/or manufacturing capabilities may not be sufficient to meet regulatory standards or receipt of required regulatory clearances or approvals, clinical results may not be replicated in actual patient settings, unforeseen global instability, including political instability, or instability from an outbreak of pandemic or contagious disease, such as the novel coronavirus (COVID-19), or surrounding the duration and severity of an outbreak, protection offered by the Company’s patents and patent applications may be challenged, invalidated or circumvented by its competitors, the available market for the Company’s products will not be as large as expected, the Company’s products will not be able to penetrate one or more targeted markets, revenues will not be sufficient to fund further development and clinical studies, our ability to obtain necessary capital when needed on acceptable terms or at all, the Company may not meet its future capital requirements in different countries and municipalities, and other risks detailed from time to time in the Company’s filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2023.
Fennec
disclaims any obligation to update these forward-looking statements except as required by law. For a more detailed discussion of related risk factors, please refer to our public filings available at and . PEDMARK® and
Fennec
® are registered trademarks of
Fennec Pharmaceuticals Inc.
©2024
Fennec Pharmaceuticals Inc.
All rights reserved. FEN-1604-v1 Investors: Robert Andrade Chief Financial Officer
Fennec Pharmaceuticals Inc.
+1 919-246-5299 Corporate and Media: Lindsay Rocco Elixir Health Public Relations +1 862-596-1304 lrocco@elixirhealthpr.com _________________________________ i Rybak L. Mechanisms of Cisplatin Ototoxicity and Progress in Otoprotection. Current Opinion in Otolaryngology & Head and Neck Surgery. 2007, Vol. 15: 364-369. ii Landier W. Ototoxicity and
Cancer
Therapy. Cancer. June 2016 Vol. 122, No.11: 1647-1658. iii Bass JK, Knight KR, Yock TI, et al. Evaluation and Management of
Hearing Loss
in Survivors of Childhood and Adolescent Cancers: A Report from the Children's Oncology Group. Pediatric Blood &
Cancer
. 2016 Jul;63(7):1152-1162.
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机构
Fennec Pharmaceuticals, Inc.
諾金有限公司
US Food & Drug Administration
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